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Improving Sleep and Reducing External Stimuli With the Maya

Primary Purpose

Critical Illness

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Maya
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult ICU, MC or CCU patients with 5 to 7 expected number of admission days
  • patients with an expected Richmond Agitation Sedation Scale (RASS) of >-3 and < +3
  • patients who speak Dutch (because of the qualitative evaluation of the Maya)

Exclusion Criteria:

  • patients with severe brain damage
  • patients with a severe psychiatric disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Group 1: Maya use on 1st, 3th and 5th day

    Group 2: Maya use on the 2nd, 4th, and 6th day

    Arm Description

    Group 1 uses the Maya on the 1st, 3th and 5th day and not on the 2nd, 4th and 6th day of their admission to either the ICU, MC or CCU.

    Group 2 uses the Maya on the 2nd, 4th and 6th day and not on the 1st, 3th, and 5th day of their admission to either the ICU, MC or CCU.

    Outcomes

    Primary Outcome Measures

    Quality of sleep
    patients' quality of sleep is measured once a day with the Richard Campbell Sleep Questionnaire (RCSQ); (minimum score 0 = worst sleep - maximum score 100 = best sleep)

    Secondary Outcome Measures

    NRS sleep
    Patients' sleep is measured once a day with the sleep numeric rating scale (NRS sleep); (minimum score 0 = worst sleep - maximum score 10 = best sleep)
    Anxiety
    Patients' anxiety is measured once a day with the Daily Assesment of symptoms of Anxiety (DAS-A); (minimum score 0 = no anxiety - maximum score 24 = a lot of anxiety)
    NRS Stress
    Patients' stress is measured once a day with the stress numeric rating scale (NRS-stress); (minimum score 0 = no stress - maximum score 10 = most imaginable stress)
    Arousal
    patients' arousal is measured once a day with the Richmond Agitation Sedation Scale (RASS); (minimum score -5 = no reaction - maximum score = 4 very agitated)
    Delirium CCU
    CCU patients' delirium is measured once a day with the delirium observation scale (DOSS); (minimum score 0 = no delirium; a score of >= 3 means delirium; maximum score 65)
    Delirium ICU/MC
    ICU/MC patients' delirium is measured once a day with the Intensive Care Delirium Checklist (ICDSC); (minimum score 0 = no delirium; a score of 1 - 3 means subsyndromal delirium; a score of 4 - 8 means delirium; maximum score 8)
    Light
    Light level (LUX). This will be measured with a validated application on a mobile phone
    Sound
    Sound levels (decibel). This will be measured with a validated application on a mobile phone
    Hart rate
    hart rate is measured with a heart rate monitor and reported every two hours as beats per minute (BPM)
    Respiratory rate
    Respiratory rate is measured every two hours with a respiratory rate monitor and reported as rate per minute
    oxygen saturation
    Oxygen saturation is measured every two hours with a oxygen saturation monitor and reported as a percentage
    Blood pressure
    Blood pressure is measured every two hours with a intra-arterial catheter or a bloodpressure cuff and reported as diastolic value and systolic value (mmHg)

    Full Information

    First Posted
    September 13, 2021
    Last Updated
    October 4, 2021
    Sponsor
    Radboud University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05078645
    Brief Title
    Improving Sleep and Reducing External Stimuli With the Maya
    Official Title
    Improving Sleep and Reducing External Stimuli With the Maya: a Pilot Study on Experience, Feasibility and Applicability
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2021 (Anticipated)
    Primary Completion Date
    June 2022 (Anticipated)
    Study Completion Date
    November 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Radboud University Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Lack of sleep is a large problem for many patients in hospitals. Common causes are nuisances by light and sound. Especially with critically ill patients in the Intensive Care unit (ICU), Medium Care Unit (MCU) and Cardiac Care Unit (CCU), who are are monitored intensively, a lack of sleep often occurs. Patients with a lack of sleep more offer suffer from delirium, are more often anxious and stressed, and have a longer length of stay in the hospital. Also, patients' lack of sleep enhances nurses workloads during nightshifts. Because of this, there is a strong need for innovative devices which aim to limit the light and sound nuisances and thereby enhance patients' quality of sleep in the ICU, MC and CCU. The Maya is a special "cover" which can be placed over the head of the bed. As a result patients are able to limit light and sound nuisances and enhance their privacy. With this pilot-study we aim to determine: The feasibility and experiences of patients and healthcare professionals with the Maya. To determine the effect size of dependent variables which can be used in future studies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Critical Illness

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Pilot study with a crossover design. Half of the patients will use the Maya on the first, third and fifth day of their admission and will not use the maya on the second fourth and sixth day (group 1). The other half will use the Maya on the second, fourth and sixth day of their admission and will not use the maya on the first, third and fifth day (group 2). Group allocation will be randomised.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1: Maya use on 1st, 3th and 5th day
    Arm Type
    Other
    Arm Description
    Group 1 uses the Maya on the 1st, 3th and 5th day and not on the 2nd, 4th and 6th day of their admission to either the ICU, MC or CCU.
    Arm Title
    Group 2: Maya use on the 2nd, 4th, and 6th day
    Arm Type
    Other
    Arm Description
    Group 2 uses the Maya on the 2nd, 4th and 6th day and not on the 1st, 3th, and 5th day of their admission to either the ICU, MC or CCU.
    Intervention Type
    Device
    Intervention Name(s)
    Maya
    Intervention Description
    The Maya is a cover which can be placed over the end of the patients bed. The Maya aims to reduce light and sound nuisances and enhance patients' privacy
    Primary Outcome Measure Information:
    Title
    Quality of sleep
    Description
    patients' quality of sleep is measured once a day with the Richard Campbell Sleep Questionnaire (RCSQ); (minimum score 0 = worst sleep - maximum score 100 = best sleep)
    Time Frame
    up to six days
    Secondary Outcome Measure Information:
    Title
    NRS sleep
    Description
    Patients' sleep is measured once a day with the sleep numeric rating scale (NRS sleep); (minimum score 0 = worst sleep - maximum score 10 = best sleep)
    Time Frame
    up to six days
    Title
    Anxiety
    Description
    Patients' anxiety is measured once a day with the Daily Assesment of symptoms of Anxiety (DAS-A); (minimum score 0 = no anxiety - maximum score 24 = a lot of anxiety)
    Time Frame
    up to six days
    Title
    NRS Stress
    Description
    Patients' stress is measured once a day with the stress numeric rating scale (NRS-stress); (minimum score 0 = no stress - maximum score 10 = most imaginable stress)
    Time Frame
    up to six days
    Title
    Arousal
    Description
    patients' arousal is measured once a day with the Richmond Agitation Sedation Scale (RASS); (minimum score -5 = no reaction - maximum score = 4 very agitated)
    Time Frame
    up to six days
    Title
    Delirium CCU
    Description
    CCU patients' delirium is measured once a day with the delirium observation scale (DOSS); (minimum score 0 = no delirium; a score of >= 3 means delirium; maximum score 65)
    Time Frame
    up to six days
    Title
    Delirium ICU/MC
    Description
    ICU/MC patients' delirium is measured once a day with the Intensive Care Delirium Checklist (ICDSC); (minimum score 0 = no delirium; a score of 1 - 3 means subsyndromal delirium; a score of 4 - 8 means delirium; maximum score 8)
    Time Frame
    up to seven days
    Title
    Light
    Description
    Light level (LUX). This will be measured with a validated application on a mobile phone
    Time Frame
    up to six days
    Title
    Sound
    Description
    Sound levels (decibel). This will be measured with a validated application on a mobile phone
    Time Frame
    up to six days
    Title
    Hart rate
    Description
    hart rate is measured with a heart rate monitor and reported every two hours as beats per minute (BPM)
    Time Frame
    up to six days
    Title
    Respiratory rate
    Description
    Respiratory rate is measured every two hours with a respiratory rate monitor and reported as rate per minute
    Time Frame
    up to six days
    Title
    oxygen saturation
    Description
    Oxygen saturation is measured every two hours with a oxygen saturation monitor and reported as a percentage
    Time Frame
    up to six days
    Title
    Blood pressure
    Description
    Blood pressure is measured every two hours with a intra-arterial catheter or a bloodpressure cuff and reported as diastolic value and systolic value (mmHg)
    Time Frame
    up to six days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: adult ICU, MC or CCU patients with 5 to 7 expected number of admission days patients with an expected Richmond Agitation Sedation Scale (RASS) of >-3 and < +3 patients who speak Dutch (because of the qualitative evaluation of the Maya) Exclusion Criteria: patients with severe brain damage patients with a severe psychiatric disorder
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bram Tilburgs, Dr.
    Phone
    0031 24 36155618
    Email
    bram.tilburgs@radboudumc.nl
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mark van den Boogaard, Dr.
    Phone
    0031 24 36155618
    Email
    mark.vandenboogaard@radboudumc.nl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bram Tilburgs, Dr.
    Organizational Affiliation
    adboudumc, intensive care, research
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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